Genzyme Receives Positive Opinion

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Genzyme Corporation (Nasdaq: GENZ) has announced that the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted a positive opinion for the marketing authorisation of the new phosphate binder Renvela (sevelamer carbonate) for use in patients with chronic kidney disease (CKD), including patients not on dialysis, with serum phosphorous levels ≥ 1.78 mmol/L (5.5 mg/dL).

Genzyme’s filing in Europe for Renvela includes both tablet and powder formulations for the control of serum phosphorus in adult hyperphosphatemic CKD patients. The CHMP opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The European Commission generally follows the advice of the CHMP, but is not obligated to do so. A decision from the European Commission is expected at the end of May.

“Upon approval this will represent a significant addition to the treatment options available to nephrologists,” said Professor Markus Ketteler, Professor of Medicine and Clinical Nephrologist, Klinikum Coburg, Academic Teaching Hospital of the University of Würzburg, Germany. “Physicians will hopefully soon have an approved non-absorbed, calcium-free phosphate binder to use with hyperphosphatemic patients, regardless of their dialysis status, with the added flexibility of a powder formulation.”

“We are delighted with this positive opinion,” said John P. Butler, President, Cardiometabolic & Renal, at Genzyme. “If confirmed by the European Commission, this will be the first phosphate binder for patients not on dialysis approved through the centralized procedure. This is an acknowledgement of the value Renvela is expected to bring to patients with CKD.”

Renvela is a next generation version of Renagel (sevelamer hydrochloride), a calcium free, metal free, non absorbed phosphate binder, and has the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within recommended KDOQI 1. range.

In the United States, Genzyme launched Renvela in its tablet formulation for patients with CKD on dialysis in March 2008. The company is also seeking FDA approvals of the powder formulation and for the treatment of hyperphosphatemic CKD patients not on dialysis.

Elevated serum phosphorus levels are common in patients with CKD because phosphorus is not easily filtered by the diseased kidneys and therefore builds up in the body. This can lead to calcification of tissues, and increased risk of cardiovascular mortality. Controlling serum phosphorus is therefore an important element in the care of patients with CKD.

1.The National Kidney Foundation’s 2003 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone Metabolism and Disease in CKD recommend sevelamer as a first-line treatment option to control phosphorus.

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